35938 Federal Register / Vol. 63, No. 126 /Wednesday, July 1, 1998 / Notices

a notice announcing the availability of

a draft guidance for industry entitled

‘‘Promoting Medical Products in a

Changing Healthcare Environment; I.

Medical Product Promotion by

Healthcare Organizations or Pharmacy

Benefits Management Companies

(PBMs)’’ that appeared in the Federal

Register of January 5, 1998 (63 FR 236).

FDA is taking this action because of the

complexity and importance of the issues

raised by this draft guidance and to

allow interested parties additional time

to prepare and submit comments.

DATES: Written comments by July 31,

1998. General comments on agency

guidance documents are welcome at any

time.

ADDRESSES: Copies of the draft guidance

for industry are available on the Internet

at http://www.fda.gov/cder/guidance/

index.htm. Submit written requests for

single copies of the draft guidance for

industry ‘‘Promoting Medical Products

in a Changing Healthcare Environment;

I. Medical Product Promotion by

Healthcare Organizations or Pharmacy

Benefits Management Companies

(PBMs)’’ to the Drug Information Branch

(HFD–210), Center for Drug Evaluation

and Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that

office in processing your request.

Submit written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Requests and comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Regarding prescription drugs: Laurie

B. Burke, Center for Drug

Evaluation and Research (HFD–40),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–2828, or via

Internet at burkel@cder.fda.gov;

Regarding prescription biological

products: Toni M. Stifano, Center

for Biologics Evaluation and

Research (HFM–200), Food and

Drug Administration, 1401

Rockville Pike, Rockville, MD

20852–1448, 301–827–3028, or via

Internet at stifano@cber.fda.gov;

Regarding restricted medical devices:

Byron L. Tart, Center for Devices

and Radiological Health (HFZ–302),

Food and Drug Administration,

2098 Gaither Rd., Rockville, MD

20850, 301–594–4639, or via

Internet at bxt@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 5, 1998 (63

FR 236), FDA published a notice

announcing the availability of a draft

guidance for industry entitled

‘‘Promoting Medical Products in a

Changing Healthcare Environment; I.

Medical Product Promotion by

Healthcare Organizations or Pharmacy

Benefits Management Companies

(PBMs).’’ The draft guidance is intended

to assist sponsors of regulated medical

products (human drugs, biologics, and

medical devices) by describing

circumstances in which they may be

held responsible for promotional

activities performed by a healthcare

organization/PBM subsidiary or by a

nonsubsidiary healthcare organization/

PBM that violate the Federal Food,

Drug, and Cosmetic Act and regulations

issued thereunder. The draft guidance

also reminds medical product sponsors

of their responsibility to submit or, in

the case of some devices, maintain

historical files of promotional labeling

and advertising. Following the review of

all comments received between January

5 and July 31, 1998, the agency intends

to solicit public comment on a new draft

guidance document.

Interested persons may, on or before

July 31, 1998, submit to the Dockets

Management Branch (address above)

written comments on this subject. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. The draft guidance and

received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: June 25, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–17413 Filed 6-30-98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Statement of Organization, Functions

and Delegations of Authority

This notice amends Part R of the

Statement of Organization Functions

and Delegations of Authority of the

Department of Health and Human

Services (DHHS), Health Resources and

Services Administration (HRSA), (60 FR

56605 as amended November 6, 1995, as

last amended at 63 FR 33379–80 dated

June 18, 1998). This notice reflects the

changes in the Bureau of Primary Health

Care (BPHC), Division of National

Health Service Corps.

I. Under Division of National Health

Service Corps (RC5) delete the current

functional statement in it’s entirety and

replace with the following:

Provides (1) strategic planning and

overall policy guidance, and program

oversight to the National Health Service

Corps (NHSC); (2) initiates national

program and policy changes, including

regulatory and statutory amendments, as

necessary, to ensure NHSC consistency

with evolving national health care

policy; (3) supports the NHSC National

Advisory Council (NAC), which advises

the Secretary, DHHS, on national health

care policy, particularly as it affects

health manpower issues and the NHSC;

(4) works with the Office of the

Administrator and the Office of the

Secretary to ensure that the NAC

membership are nationally recognized

leaders in national health care policy

issues, and in their respective primary

health care disciplines; (5) provides

national NHSC leadership, integration

and coordination with BPHC, HRSA and

other Departmental programs serving or

impacting the Nation’s underserved

communities and populations; (6) works

directly with Bureau, Agency and intraAgency, Departmental, and interDepartmental organizations and staffs,

as appropriate, on national policies and

strategies affecting underserved

populations and development and

distribution of primary care clinical

personnel; (7) coordinates with the

Bureau of Health Professions regarding

health professionals education and

training, as appropriate; (8) speaks for

NHSC with national, regional, State, and

local public and private health care

professional associations, universities

and other health professions training

institutions and other groups whose

public policy interests relate to primary

health care manpower and access

issues; (9) articulates NHSC policy

interests and issues to a variety of

national forums, including universities,

foundations, think tanks, and other

organizations whose interests in

primary and other health care public

policy issues have potential for affecting

the NHSC; (10) provides policy

guidance and support to HRSA field

offices, and to State and Regional

Primary Care Offices and Primary Care

Associations; and (11) coordinates

NHSC and Bureau policy on primary

and other health care manpower issues,

and works with a wide variety of

national, regional, State and local

constituencies in ensuring their

effective implementation.
Federal Register / Vol. 63, No. 126 /Wednesday, July 1, 1998 / Notices 35939

II. Delegations of Authority

All delegations and redelegations of

authority which were in effect

immediately prior to the effective date

hereof have been continued in effect in

them or their successors pending further

redelegation. I hereby ratify and affirm

all actions taken by any DHHS officials

which involved the exercise of these

authorities prior to the effective date of

this delegation.

This reorganization is effective upon

date of signature.

Dated: June 19, 1998.

Claude Earl Fox,

Administrator.

[FR Doc. 98–17472 Filed 6–30–98; 8:45 am]

BILLING CODE 4160–15–U

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Notice of Receipt of Applications for

Permit

The following applicants have

applied for a permit to conduct certain

activities with endangered species. This

notice is provided pursuant to Section

10(c) of the Endangered Species Act of

1973, as amended (16 U.S.C. 1531, et

seq.):

PRT–843092

Applicants: San Antonio Zoological Gardens

and Aquarium, San Antonio. TX.

The applicant requests a permit to

import 4.4 live Japanese Giant

Salamanders (Andrias japonicus), bred

in captivity by the Asa Zoological Park,

Hiroshima, Japan, for the purpose of

enhancement of the species through

captive breeding and exhibition.

PRT–841435

Applicant: Panamerican Marketing, San

Antonio, TX.

The applicant requests a permit to

export 1.2 live ring-tailed lemurs (Lemur

catta) to Promotora Zoofari, Morelos,

Mexico for the purpose of enhancement

of the propagation and survival of the

species through captive breeding.

PRT–831689

Applicant: University of Wisconsin, Dept. of

Zoology, Madison, WI.

The applicant requests a permit to

import blood and feather samples taken

from captive-held and wild caught

Andean condors (Vultur gryphus) in

South America, for the purpose of

scientific research.

PRT–844311

Applicant: Geraldine Mr. Stallman, Salem,

WI.

The applicant requests a permit to

import the sport-hunted trophy of one

male bonetebok (Damaliscus pygargus

dorcas) culled from a captive herd

maintained under the management

program of the Republic of South Africa,

for the purpose of enhancement of the

survival of the species.

Writtend data or comments should be

submitted to the Director, U.S. Fish and

Wildlife Service, Office of Management

Authority, 4401 North Fairfax Drive,

Room 700, Arlington, Virginia 22203

and must be received by the Director

within 30 days of this publication.

Documents and other information

submitted with these applications are

available for review, subject to the

requirements of the Privacy Act and

Freedom of Information Act, by any

party who submits a written request for

a copy of such documents to the

following office within 30 days of the

date of publication of this notice. U.S.

Fish and Wildlife Service, Office of

Management Authority, 4401 North

Fairfax Drive, Room 700, Arlington,

Virginia 22203. Phone: (703/358–2104):

FAX: (703/358–2281).

Dated: June 26, 1998.

MaryEllen Amtower,

Acting Chief, Branch of Permits, Office of

Management Authority.

[FR Doc. 98–17524 Filed 6–30–98; 8:45 am]

BILLING CODE 4310–55–U

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Notice of Intent To Issue 2 Draft

Comprehensive Conservation Plans

and Associated Environmental

Assessments for 2 National Wildlife

Refuges in the Southwest Region

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice.

SUMMARY: This notice advises the public

that the U.S. Fish and Wildlife Service

(Service) has prepared draft

Comprehensive Conservation Plans

(CCP) and associated Environmental

Assessments for the Bitter Lake National

Wildlife Refuge, Roswell, New Mexico,

and San Andres National Wildlife

Refuge, Las Cruces, New Mexico

pursuant to the National Wildlife Refuge

System Improvement Act of 1997, and

National Environmental Policy Act of

1969, and its implementing regulations.

DATES: The Service will be open to

written comments through July 30,

1998.

ADDRESSES: Copies may be obtained by

writing to: Mr. Tom Baca, Natural

Resource Planner, Division of Refuge,

U.S. Fish and Wildlife Service, P.O. Box

1306, Albuquerque, NM 87103–1306.

Comments should be submitted to: Lou

Bridges, Project Coordinator, Research

Management Consultants, Inc., 1746

Cole Blvd., Bldg. 21, Suite 300, Golden,

CO 80401.

SUPPLEMENTARY INFORMATION: It is

Service policy to have all lands within

the National Wildlife Refuge System

managed in accordance with an

approved CCP. The CCP guides

management decisions and identifies

refuge goals, long-range objectives, and

strategies for achieving refuge purposes.

The planning process has considered

many elements, including habitat and

wildlife management, habitat protection

and acquisition, public and recreational

uses, and cultural resources. Public

input into this planning process has

assisted in the development of the draft

documents. The CCP will provide other

agencies and the public with a clear

understanding of the desired conditions

for the Refuges and how the Service will

implement management strategies.

The Service intends to consider

comments and advice generated in

response to the draft documents prior to

the preparation of a final CCP. The

Service is furnishing this notice in

compliance with Service CCP policy: (1)

To advise other agencies and the public

of the availability of the draft

documents, and (2) to obtain

suggestions and advice for consideration

in preparation of final documents.

The Service anticipates that final CCP

documents and any associated NEPA

documents will be available by

September 15, 1998.

Dated: June 26, 1998.

Renne Lohefner,

Acting Regional Director.

[FR Doc. 98–17460 Filed 6–30–98; 8:45 am]

BILLING CODE 4310–55–U

DEPARTMENT OF THE INTERIOR

Bureau of Indian Affairs

Notice of Intent To Prepare an

Environmental Impact Statement for

the White River Amphitheatre,

Muckleshoot Indian Reservation, King

County, WA

AGENCY: Bureau of Indian Affairs,

Interior.

ACTION: Notice of intent and public

scoping notice.

SUMMARY: This notice advises the public

that the Bureau of Indian Affairs, with

the cooperation of the U.S. Army Corps

of Engineers, U.S. Environmental